lca discussion forum 65 / may 24, 2017 regulation of ...may 24, 2017 · 10% tio2 90% fe2o3 100%...
TRANSCRIPT
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Regulation of Nanomaterials – the relevance of LCA and RA Tobias Walser, PhD
LCA Discussion Forum 65 / May 24, 2017
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A look back into the outlook of DF38, 2009
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Designed Nanomaterials
May 24, 2017 Walser et al., Nature Nanotechnology, 2012
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Disposal of Nanomaterials
Walser et al., Nature Nanotechnology, 2012 May 24, 2017
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Disposal of Nanomaterials
May 24, 2017 Walser et al., Nature Nanotechnology, 2012
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Too many regulatory definitions lead to confusion
May 24, 2017
Why a definition? Reporting and assessment of nanospecific properties of new chemicals
Definitions Vary between countries and regulations
Consensus None, maybe 100 nm in one dimension
Example Switzerland Chemicals Pharmaceuticals
Nanomaterial: Material, welches Partikel in ungebundenem Zustand, als Aggregat oder als Agglomerat enthält, bei
welchen ein oder mehrere Aussenmasse im Bereich von 1 bis 100 nm liegen oder ein Material, das ein spezifisches Oberflächen-Volumen-Verhältnis von über 60 m2/cm3 aufweist. Ein Material gilt nur dann als Nanomaterial, wenn es gezielt zur Nutzung der Eigenschaften hergestellt wird, die sich aus den genannten Aussenmassen der enthaltenen Partikel oder dem genannten Oberflächen-Volumen-Verhältnis des Materials ergeben. Fullerene, Graphenflocken und einwandige Kohlenstoff-Nanoröhren mit einem oder mehreren Aussenmassen unter 1 nm gelten als Nanomaterialien.
Nanopartikel: mindestens eine Dimension im Grössenbereich 1-1000 nm sowie eine auf nanotechnologische Eigenschaften basierende Funktion/Wirkungsweise
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Nanomaterial Definitions: Beyond size and composition
May 24, 2017
US EPA 2012
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• Uncoated nanomaterials consisting of different substances
• Coated nanomaterials with sealed or permeable surface
• Aggregates or agglomerates of different nanomaterials
Nanomaterial Definitions: Beyond size and composition
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Not definition, but characterization matters!
Fiber Paradigm for 1 dimension
> 5 µm
Chemical composition Size distribution Shape Coating or
Functionalizationn
Core Material
2.5 < C ≤ 10%
10 < C ≤ 25% 25 < C ≤ 100%
C ≤ 2.5% 2.5 < C ≤ 10%
10 < C ≤ 25%
25 < C ≤ 100% Sphere
Tube Rod
Plate
Wide or narrow
21 < S ≤ 500 nm 1 < S ≤ 20 nm
C ≤ 2.5%
Walser and Studer (2015): Sameness: The regulatory crux with nanomaterial identity and grouping schemes for hazard assessment. Reg.Tox.Pharm (72): 569–571
65 nm
10% TiO290% Fe2O3
100% SiO2
80 nm
3% TiO297% Fe2O3
100% SiO2
NM 1 NM 2
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Robust Study Summaries: Requested (additional) parameters
Chemical composition (incl. crystalline structure)
Impurities Surface chemistry Size Shape Surface area Solubility (rate)
Dispersibility Dustiness Biological reactivity
(e.g. ROS formation) Photoreactivity Stability in storage Rigidity for fibers
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Risk Assessment is used for Regulatory Assessments of Chemicals Hazard identification Hazard assessment, incorporating the dose-response relationships Exposure assessment Risk characterisation, integration of hazard and exposure assessments
R = f ( D , H )
Tobias Walser May 24, 2017
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Risk Assessment is used for Regulatory Assessments of Chemicals
REACH Appendix 4: Recommendations for nanomaterials applicable to the Guidance on Registration, Draft Public Version, May 2016 REACH Appendix R.6-1: Recommendations for nanomaterials applicable to the Guidance on QSARs and Grouping, Draft Public Version, May 2016
A variety of tools are available to guide industry through the registration process (Europe: European Chemicals Agency ECHA) Data provider is industry (Safety Dossier). At the same time they are responsible for classification, labelling and packaging (CLP) of the chemical. Nanomaterials:The same aspects as conventional chemicals plus nanospecific properties, plus: Exposure pathways Altered behaviour in the environment and the human body Mode of actions …
Tobias Walser May 24, 2017
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Combined use of LCA, RA, and HBM for Chemicals, CS Nanomaterials
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Complementary information from LCA
Time span
Geographic specificity
Population or
individual impact?
Data demand
Granularity of data Informative
value for regulators
Regulatory use
LCA Integrated Rather generic
(sub-) population
impact
Low to high, LCA
practitioner decides
Coarse but comprehensi
ve
Low, expert knowledge
needed
Low, but slowly
developing
RA Specific point in
time
Rather specific
Individual health risk
Rather high,
tonnage and hazard triggered
Fine, case specific
High, tiered testing
Fully implemented
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Combined use of LCA and RA for Nanomaterials
adapted from Walser et al. 2017 (Environmental Impact Assessment Review Volume 65, July 2017, Pages 156–163)
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Cumulative Exposure in Regulatory Risk Assessment
Walser et al. 2017 (Environmental Impact Assessment Review Volume 65, July 2017, Pages 156–163)
• 3 products, each releasing the same nanomaterials. Industry perspective vs. perspective of regulators
• How to estimate the «true exposure»?
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Policy decisions based on LCA studies of an entire sector
• 3 products, each releasing nanomaterials. Industry perspective vs. perspective of policy makers
• Product sector: Lowering the impact of all products equally? Or focusing on the «worst»?
Walser et al. 2017 (Environmental Impact Assessment Review Volume 65, July 2017, Pages 156–163)
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Using the Strenghts of LCA and RA for Chemical Assessment
Walser et al. 2017 (Environmental Impact Assessment Review Volume 65, July 2017, Pages 156–163)
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Keep in mind
• LCA & RA practitioners: Be transparent, report assumptions and uncertainties
• LCA developers: standardization, transparency of industrial data, comprehensive and valid data for product sectors
• Industry: Be agile, and adapt to regulatory changes and new knowledge
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Thank you for your attention! [email protected]
Complex chemicals or materials? - We build bridges betweenScience, Regulation, and Industry.
Kickoff: July 2017
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Backup: It is worth looking into regulation
Market success?
A promising new nanomaterial or
nanoproduct
Country and Quantity Regulatory Area «Soft and hard»
regulation Increasing regulatory requirements
Tonn
age
Dossier 1 D2 D3